OncoMatch/Clinical Trials/NCT03428802
Pembrolizumab in Treating Participants With Metastatic, Recurrent or Locally Advanced Cancer and Genomic Instability
Is NCT03428802 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Pembrolizumab for brca1 gene mutation.
Treatment: Pembrolizumab — This phase II trial studies how well pembrolizumab works in treating participants with cancer that has spread to other places in the body, has come back or has spread to nearby tissues or lymph nodes. Monoclonal antibodies such as, pembrolizumab, may interfere with the ability of tumor cells to grow and spread.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Ovarian Cancer
Breast Carcinoma
Biomarker criteria
Required: BRCA1 mutation
Required: BRCA2 mutation
Required: POLD1 mutation
Required: POLE mutation
Disease stage
Required: Stage III, IV, STAGE III BREAST CANCER AJCC V7, STAGE IIIA BREAST CANCER AJCC V7, STAGE IIIB BREAST CANCER AJCC V7, STAGE IIIC BREAST CANCER AJCC V7, STAGE IV BREAST CANCER AJCC V6 AND V7, STAGE III OVARIAN CANCER AJCC V8, STAGE IIIA OVARIAN CANCER AJCC V8, STAGE IIIB OVARIAN CANCER AJCC V8, STAGE IIIC OVARIAN CANCER AJCC V8, STAGE IV OVARIAN CANCER AJCC V8, STAGE IVA OVARIAN CANCER AJCC V8, STAGE IVB OVARIAN CANCER AJCC V8
advanced cancer (metastatic, recurrent or locally advanced) and measurable disease based on RECIST 1.1
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-PD-1 therapy
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
Cannot have received: anti-cancer monoclonal antibody
Exception: within 4 weeks prior to study day 1 or not recovered from adverse events
Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study day 1 or who has not recovered (i.e., ≤ grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier
Cannot have received: chemotherapy
Exception: within 2 weeks prior to study day 1 or not recovered from adverse events
Has had prior chemotherapy ... within 2 weeks prior to study day 1 or who has not recovered (i.e., ≤ grade 1 or at baseline) from adverse events due to a previously administered agent
Cannot have received: targeted small molecule therapy
Exception: within 2 weeks prior to study day 1 or not recovered from adverse events
Has had prior ... targeted small molecule therapy ... within 2 weeks prior to study day 1 or who has not recovered (i.e., ≤ grade 1 or at baseline) from adverse events due to a previously administered agent
Cannot have received: radiation therapy
Exception: within 2 weeks prior to study day 1 or not recovered from adverse events
Has had prior ... radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., ≤ grade 1 or at baseline) from adverse events due to a previously administered agent
Lab requirements
Blood counts
ANC ≥ 1,500 /mcL; Platelets ≥ 100,000 /mcL; Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L without transfusion or EPO dependency
Kidney function
Serum creatinine ≤ 1.5 X ULN OR measured/calculated creatinine clearance ≥ 60 mL/min for subjects with creatinine > 1.5 X ULN
Liver function
Serum total bilirubin ≤ 1.5 X ULN OR direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN; AST and ALT ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases; Albumin ≥ 2.5 mg/dL
ANC ≥ 1,500 /mcL ... Platelets ≥ 100,000 / mcL ... Hemoglobin ≥ 9 g/dL ... Serum creatinine ≤ 1.5 X ULN OR ... creatinine clearance ≥ 60 mL/min ... Serum total bilirubin ≤ 1.5 X ULN OR direct bilirubin ≤ ULN ... AST and ALT ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases ... Albumin ≥ 2.5 mg/dL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Rutgers Cancer Institute of New Jersey · New Brunswick, New Jersey
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Health · New York, New York
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